- Repligen (Waltham, MA)
- … public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... processes including all global subsidiaries. Reporting directly to the VP Corporate Controller,...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting ... Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... you thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
- CBRE (Boston, MA)
- Business Development Senior Director , Global Occupier Accounts Job ID 210942 Posted 02-May-2025 Service line GWS Segment Role type Full-time Areas of ... Senior Managing Director , Business Development** The Senior Business Development Director , Global ... executives. + Possess a sufficient understanding of healthcare regulatory compliance, including, but not limited to, TJC, DNV,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for ... activities in support of domestic and international clinical development initiatives. The Senior Director , GCD works in a multidisciplinary matrix environment… more
- Veralto (Waltham, MA)
- …of collaboration and continuous learning. **About the Role:** Veralto is seeking a ** Senior Director ,** **Gl** **obal Payroll** to contribute to the mission of ... a safer world and a more sustainable future. When you join Veralto's vibrant global network of 13 operating companies and 16,000 associates, you join a unique… more
- ThermoFisher Scientific (Waltham, MA)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** The Senior Director , Pharma Services Group (PSG) Global Controller acts as a ... activities of PSG, ensuring compliance with US GAAP, SOX, internal policies, and other regulatory standards. + Lead a team of senior -level divisional and site… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... of your future at Takeda. Join us as a Senior Medical Director - GI & Inflammation- Rheumatology,...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to mechanism of action . Preferably with expertise Neurology or Psychiatry . Regional/ global Regulatory requirements . GCP/ICH . Emerging research in designated ... of your future at Takeda. Join us as a Senior Medical Director , Clinical Science Neuroscience, Sleep...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...as the Regulatory reviewer for assigned products. This position is responsible… more
- Sanofi Group (Cambridge, MA)
- …products, departmental activities, and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance and ... **Job Title:** Director , US Regulatory Affairs - Advertising...helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Research Director , Ophthalmology **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future ... be critical in helping our teams accelerate progress. The Senior Clinical Research Director (CRD) is an...development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other… more
- BeOne Medicines (Cambridge, MA)
- …and to expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assess impact of changes on business and ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA,...+ Facilitate policy and development of standard interpretation of global regulation. + Trains, develops, and manages an effective… more
